From Jim Mittler, Medical Director, PhD, Palio
We’ve all seen bad drug advertisements – confusing concepts, poorly written or too much copy, disconnected visual elements, etc. The FDA is now stepping up their monitoring for bad ads, but not for the creative aspects or connection to the brand. (Although, in some cases I wish there was an organization that could pull poorly executed creative.)
Last week, the FDA announced the launch of the “Bad Ad Program,” which is an educational outreach effort to encourage physicians to do what the Division of Drug Marketing, Advertising, and Communications (DDMAC) can’t necessarily do – monitor what is communicated during face-to-face interactions with pharmaceutical representatives. Traditionally, DDMAC reviews promotional materials developed by pharmaceutical companies (eg, journal ads, TV commercials, sales aids, or slide kits) to ensure that information is on-label and accurately portrays the efficacy of a drug while clearly stating the potential risks so that physicians can make informed prescribing decisions. Through the Bad Ad Program, DDMAC will seek to educate HCPs on what constitutes inappropriate promotional activities and will encourage HCPs to report possible violations. So not only is the content of promotional materials monitored, but by using HCPs as their agents, how these materials are used and the information articulated can also be monitored by DDMAC.
What this means is that verbal communications that occur in promotional settings such as sales representative office visits and industry-sponsored dinner and speaker programs could be under scrutiny. In the current conservative environment, sales reps are careful not to discuss off-label use or overstate the efficacy of a drug. Now, glancing over the safety data in a sales aid or the Important Safety Information slide during a presentation is frowned upon, as it should be. However, the increased scrutiny by HCPs could deter sales reps from deviating from a predetermined script and they could lose meaningful conversations out of fear that they could misspeak or be misinterpreted, and subsequently be reported to DDMAC. It may be difficult for DDMAC to determine what was discussed in a private meeting; however, according to FDA officials, if there is systematic misrepresentation, FDA reviewers will be able to spot similar complaints about a drug coming from multiple doctors, which would signal DDMAC to investigate.
The question remains if HCPs will take the time to report anything they feel is misleading or inappropriate. Additionally, will this enhanced surveillance lead to increased enforcement? The FDA has gotten tougher on promotional materials developed by drug marketers. Issuance of enforcement letters is higher than it has been in the past, with 31 warning letters already issued by DDMAC through May 2010 (which is on pace to exceed the 41 letters issued in 2009 and tops the 21 letters issued in 2008). However, if a high volume of complaints arise, there are questions regarding how the FDA will be able to investigate and issue timely corrective action due to the limited resources within the FDA. Regardless, even if DDMAC enforcement is logistically problematic, the Bad Ad Program could be a deterrent and improved compliance to DDMAC regulatory principles on the part of the pharmaceutical companies is sure to follow.Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media.